• To conduct various types of audits to work closely with BSI clients to help them improve their performance by assessing their systems and processes against BSI standards.• Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.• Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.• Maintain overall account responsibility and accountability for nominated accounts to ensure an effective partnership, whilst ensuring excellent service delivery and account growth.• Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team.• Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.• Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.• Plan/schedule workloads to make best use of own time and maximize revenue-earning activity.

• Assume the responsibilities of Management Representative.• Maintain the Quality System in compliance with FDA quality system requirements and ISO 13485 standards for Design Controls, Good Manufacturing Practices (GMPs), Document Controls, Risk Analysis, and Supplier Quality.• Organize internal/external audits and Management Review meetings. • Lead QA/QC team to investigate manufacturing quality and compliance issues (e.g. complaints, CAPAs, non-conformances, audit observations.) for all production processes prior to final product release based on engineering principles. • Oversee testing (including writing and executing protocols – IQ, OQ, PQ) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/equipment.• Assigns support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and coordinates technician work (as needed/as required). • Works in a team environment, including the ability to manage vendors and project stakeholders.• Manages competing priorities in a fast-paced environment.• Builds productive internal/external working relationships• Develops solutions to a variety of problems of scope and complexity.• Contributes to and champions process improvements.

• Responsible for the management of the entirety of the environmental monitoring program for ISO Class 7 and Class 8 Cleanrooms. • Directly responsible for the management of over 300 domestic and international suppliers utilized to manufacture numerous different high risk medical device and pharma-combination product lines. • Leading and participating in team risk management activities.• Responsible for the gamma sterilization program and initial and ongoing sterilization validations studies. • Leading process validation activities including IQ/OQ/PQ, Characterization Studies, Equipment Qualifications, Gage R&R studies. • Conducting supplier audits as a lead auditor including developing audit plans, reports, auditing templates / checklists, and follow up for any nonconformances identified. • Familiar with a variety of statistical techniques including SPC, DOE, ANOVA, T-Test, Process Capability, Sampling Plans.

• Providing external audit support as the back room lead for notified body inspections as well as ensuring all required preparation activities are completed. • Administrating the internal audit system including maintaining the internal audit schedule and tracking nonconformances, audit findings, and opportunities for improvement through to closure.• Supporting audit, CAPA, and NC root cause investigations and associated corrective actions utilizing appropriate tools such as 5-why analysis, fishbone diagrams, and affinity diagrams. • Successfully designed, developed, configured, validated, and implemented the new CATSWeb electronic complaint management system including; project management, software design requirements, user requirements, process specifications, functional requirements, software design/development, problem solving, software configuration, software validation and validation writing, software implementation, writing procedures/work instructions, and development/implementation of training program.• Responsible for reviewing of all complaint & customer feedback events to ensure accuracy & validity.• Identifying & managing complaint investigation requirements & processing complaints to closure.• Developing & providing statistical analysis of complaint trend data for complaint review boards and post market meetings. • Serving as CATSWeb administrator including providing support to users and executing required changes/updates to the system while maintaining the validation state.• Serving as CAPA administrator including scheduling regular CAPA meetings to review the status & associated metrics & ensuring CAPA files meet all regulatory and internal requirements.• Preparing & reporting on quality system metrics utilizing statistical techniques for Management Review trending.

• Developed and conducted Quality System Requirements training for the site covering 21 CFR Part 820, ISO 13485, GMP and GDP topics. • Coordinated, monitored, maintained, and documented all training activities as well as conducting training plan reviews, assessing new employee training needs, and working with electronic software training platforms (i.e. TRACE).• Managed the document control process, including reviewing, routing, approving, monitoring, implementing, and ensuring timely completion for all document change orders.

• Coordinating, monitoring, maintaining, and documenting all training activities for the site and surgical business unit. • Facilitating the document control process as the site administrator, including reviewing, routing, approving, monitoring and ensuring timely completion for all document change orders.• Facilitating the change control process as the site and surgical administrator, including reviewing, routing, approving, elevating appropriate requests, monitoring, ensuring timely completion for all change control requests, and overseeing site and surgical board meetings for monthly review of change requests. • Conducting internal audits of various quality system elements to ensure compliance to all applicable standards, regulations, policies, and procedures.• Overseeing internal and external inspections as a part of the audit management backroom team, including inspections by TGA, LGA, and TUV regulatory bodies. • Serving as a site Nonconformance (NC) / Corrective and Preventive Actions (CAPA) board administrator; including reporting data to management at monthly review boards, providing both initial and final risk assessments for owners, approving the closure of NCs / CAPAs, and providing guidance and support on the electronic data management system and compliance to the process.• Managing CAPAs and NCs from all sources (internal manufacturing, internal audits, external audits) through the entirety of the processes including investigation, risk analysis, root cause analysis, action implementation, and effectiveness verification.• Generating and presenting metrics on training, document control, and change control processes.

• Provided general guidance of CAPA activities and documentation to assure compliance with corporate, sector and site CAPA policies and procedures, FDA regulations, ISO 13485, MDD, PAL and Medical Device Requirements.• Coordinated all CAPA related activities, including participating in cross-functional root-cause analyses, providing consultation to CAPA-owners, ensuring timely completion and verifying effectiveness of actions taken. • Maintained the electronic and paper-based data management system and ensuring accuracy of quality records.• Compiled CAPA trend data and reported the data to management at monthly Quality Review meetings. • Participated in internal and external audits of the Quality System by addressing auditor questions and facilitated the administrative aspects of the audit, including a FDA inspection.• Assessed the adequacy of the local quality system by performing gap analysis when new corporate or sector procedures are issued and coordinating procedure updates.• Developed and implemented a new system and procedure for addressing audit findings.• Gained experience in supplier quality by developing a tracking system for tracking supplier corrective action responses.• Gained experience in sterilization processes by preparing bioburden, EtO, and E-beam samples, analyzing laboratory results, and documenting through protocols and reports.• Supported the organization’s Quality System by ensuring compliance with FDAs Quality System Requirements and ISO 13485.• Performed manufacturing line audits to identify discrepancies between procedures and practices as well as identifying other compliance risks and opportunities for improvement.• Supported engineers on protocol execution by generating inspection reports and technical documentation to qualify and validate tooling.

• Developed and implemented research plans for hospitals and biotech companies’ research information; while recording results in self-generated Excel spreadsheets for tracking.

• Gained experience with research skills in the field of genetics.